FDA Orange Book
Is there a generic for Parsabiv?
Parsabiv contains etelcalcetide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Parsabiv (etelcalcetide). The Orange Book shows its last listed patent expires June 27, 2034.
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Parsabiv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10MG/2ML (5MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 2.5MG/0.5ML (2.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 5MG/ML (5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 208325, held by KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Parsabiv patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9701712 | July 29, 2030 | Drug substance, Drug product | U-2014 | 208325 |
| 9278995 | July 29, 2030 | Drug substance | None | 208325 |
| 8377880 | July 29, 2030 | Drug substance, Drug product | None | 208325 |
| 8999932 | February 7, 2031 | Drug substance, Drug product | U-2014 | 208325 |
| 11959486 | June 27, 2034 | Drug product | U-2014 | 208325 |
| 10344765 | June 27, 2034 | Drug product | None | 208325 |
| 11162500 | June 27, 2034 | Drug product | None | 208325 |
| 9820938 | June 27, 2034 | Drug product | None | 208325 |
Parsabiv NDC codes
Questions
Is there a generic for Parsabiv?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Parsabiv (etelcalcetide). The Orange Book shows its last listed patent expires June 27, 2034.
What is the generic name for Parsabiv?
The active ingredient in Parsabiv is etelcalcetide, per the FDA Orange Book.
When does the Parsabiv patent expire?
The last patent listed for Parsabiv in the Orange Book expires June 27, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.